[Remote] Senior Principal Scientist, Regulatory Liaison

Note: The job is a remote job and is open to candidates in USA. Merck is a pharmaceutical company seeking a Senior Principal Scientist, Regulatory Liaison to lead worldwide regulatory strategies for assigned General Medicine projects, with a focus on immunology development programs. The role provides global regulatory oversight, leads cross-functional regulatory teams, manages agency interactions and submissions, and supports products throughout their life cycle.


Responsibilities

  • Works both independently and as a team member with integrity, precision, accomplishment, respect, inclusion and a strategic mindset
  • Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies
  • Utilizes regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
  • Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle
  • Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
  • Coordinates the preparation, submission and follow-up communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation
  • Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
  • Interacts independently with regulatory agencies (FDA, EMA, etc.), including leading of regulatory meetings, teleconferences, and written communications
  • Leads cross-functional efforts to prepare for FDA advisory committees, as applicable
  • Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
  • Prepares IND/CTAs for global studies related to investigational drugs/biologics
  • Participates in regulatory due diligence activities for licensing candidate reviews

Skills

  • B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory or
  • M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory
  • Strong strategic thinking, problem-solving, and continuous learning mindset
  • Effective communicator—both written and verbal—with the ability to influence, lead, and negotiate across levels and functions
  • Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA)
  • Demonstrated expertise in leading regulatory strategies across global regions
  • Global regulatory affairs experience in major markets (U.S., EU, Japan, China)
  • Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities
  • Drug Development
  • Global Regulatory
  • Pharmaceutical Industry
  • Pharmaceutical Research
  • Product Registrations
  • Regulatory Affairs Management
  • Regulatory Communications
  • Regulatory Documents
  • Regulatory Processes
  • Regulatory Strategies
  • Regulatory Strategy Development
  • Regulatory Submissions
  • Strategic Leadership
  • Prior experience in Immunology is strongly preferred
  • Therapeutic area expertise in immunology
  • Small and large molecule experience
  • Prior people management experience
  • Immunology

Benefits

  • Annual bonus and long-term incentive, if applicable
  • Medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • Retirement benefits, including 401(k)
  • Paid holidays, vacation, and compassionate and sick days
  • Remote work

Company Overview

  • Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases. It was founded in 1891, and is headquartered in Rahway, New Jersey, USA, with a workforce of 10001+ employees. Its website is

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